Articles, App Notes, Case Studies, & White Papers

1. AI: The New Partner In Medical Device Development 6/4/2024

   Involving users in the development process and staying informed about regulatory policies can help ensure AI-powered devices meet the needs of patients and healthcare professionals.

2. How Approved Drugs Have Evolved Since The '70s

   Drugs have become more lipophilic and complex in structure over time. Innovative strategies are needed to improve the bioavailability of these new drugs.

3. PHI And Medical Devices: What Device Manufacturers Need To Know 10/16/2025

   Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.

4. Improve Solubility And Spray Drying Throughput For Brick Dust Compounds

   This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

5. Navigating The Analytical Challenges Of Complex ADCs 10/14/2026

   Antibody drug conjugates are expanding to deliver diverse therapeutic payloads. Advanced analytical strategies are required to characterize these evolving platforms.

6. The Challenges And Opportunities Of Real-World Evidence 12/12/2024

   The FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.

7. Responding To Trends In Prefilled Delivery: Component Assessment And Selection

   Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.

8. Delivering Market Success For Pharma Partners From Concept To Patient

   The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.

9. The Largest LOE Event In US Pharma History

   Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

10. Solving The Silicone Challenge In Pre-Fillable Syringes 8/27/2024

    Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.